KLS Martin SE & Co. KG

FDA Device Registration & Listing · Muhlheim/Donau Baden-Wurttemberg, DE · Registration 9610905

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610905
FEI Number
3002807464
Entity Name
KLS Martin SE & Co. KG
City/State/Country
Muhlheim/Donau Baden-Wurttemberg, DE
Establishment Address
Kolbinger StraBe 10, Muhlheim/Donau Baden-Wurttemberg 78570, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
KLS Martin SE & Co. KG (Owner Number: 10089006)
Owner / Operator Contact Address
KLS Martin Platz 1, Tuttlingen, DE-BW 78532, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2023-10-27
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-10-27
DZN Instruments, Dental Hand Dental Class 1 872.4565 2023-10-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-27
JXX Forceps, Wire Closure, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2023-10-27
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 2023-10-27
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2025-02-21
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-10-28
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2023-10-28
GDJ Clamp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-10-27
HXE Fork Orthopedic Class 1 888.4540 2023-10-27
KBL Depressor, Metal Tongue, Surgical Ear, Nose, Throat Class 1 874.4420 2023-10-27
GXL Screwdriver, Skullplate Neurology Class 1 882.4900 2025-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2023-10-27
JYG Curette, Ear Ear, Nose, Throat Class 1 874.4420 2023-10-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
HRT Stripper, Surgical Orthopedic Class 1 888.4540 2023-10-27
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2023-10-27
GAD Retractor General, Plastic Surgery Class 1 878.4800 2023-10-27
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-10-27
MOQ Battery, Replacement, Rechargeable General, Plastic Surgery Class 1 878.4820 2023-10-30
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2023-10-27
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2023-10-30
HXD Clamp General, Plastic Surgery Class 1 878.4800 2023-10-27
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2023-10-30
PGW Ear, Nose, And Throat Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
HNW Dilator, Lachrymal Ophthalmic Class 1 886.4350 2023-10-27
JYQ Loop, Wire Ear, Nose, Throat Class 1 874.4420 2023-10-30
JYR Nipper, Malleus Ear, Nose, Throat Class 1 874.4420 2023-10-27
KTG Knife, Ent Ear, Nose, Throat Class 1 874.4420 2023-10-27
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2023-10-30
JEY Plate, Bone Dental Class 2 872.4760 2023-10-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
GWX Fork, Tuning Neurology Class 1 882.1525 2023-10-30
HXC Wrench Orthopedic Class 1 888.4540 2023-10-30
JEY Plate, Bone Dental Class 2 872.4760 2023-10-27
HXX Screwdriver Orthopedic Class 1 888.4540 2023-10-27
HNQ Hook, Ophthalmic Ophthalmic Class 1 886.4350 2023-10-30
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2023-10-27
HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology Class 1 884.4530 2023-10-27
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-10-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
JYL Hook, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2023-10-30
HNR Forceps, Ophthalmic Ophthalmic Class 1 886.4350 2023-10-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-16
KAQ Gouge, Nasal, Ent Ear, Nose, Throat Class 1 874.4420 2023-10-30
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2023-10-27
DZL Screw, Fixation, Intraosseous Dental Class 2 872.4880 2023-10-27
HTE Elevator General, Plastic Surgery Class 1 878.4800 2023-10-30
JZF Tube, Ear Suction Ear, Nose, Throat Class 1 874.4420 2023-10-30
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2023-10-30
HXS Twister, Wire Orthopedic Class 1 888.4540 2023-10-27
KCG Dilator, Tracheal Ear, Nose, Throat Class 1 874.4420 2023-10-30
GDR Saw, Manual And Accessories General, Plastic Surgery Class 1 878.4800 2023-10-30
EMF Knife, Surgical General, Plastic Surgery Class 1 878.4800 2023-10-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-27
HTD Forceps General, Plastic Surgery Class 1 878.4800 2023-10-27
ELE Implant, Subperiosteal Dental Class 2 872.3645 2023-10-28
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-10-27
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 2023-10-27
HBW Fastener, Plate, Cranioplasty Neurology Class 2 882.5360 2023-10-28
GWO Plate, Cranioplasty, Preformed, Alterable Neurology Class 2 882.5320 2023-10-28
PBJ Cranial Distraction System Neurology Class 2 882.5330 2023-11-27
GDL Needle, Suturing, Reusable General, Plastic Surgery Class 1 878.4800 2023-10-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
HXW Bender Orthopedic Class 1 888.4540 2023-10-27
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2023-10-27
JYZ Rod, Measuring Ear Ear, Nose, Throat Class 1 874.4420 2023-10-30
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2023-10-30
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2023-10-27
DWS Instruments, Surgical, Cardiovascular Cardiovascular Class 1 870.4500 2023-10-27
JEY Plate, Bone Dental Class 2 872.4760 2023-10-27
EMG Forceps, Tooth Extractor, Surgical Dental Class 1 872.4565 2023-10-27
JEY Plate, Bone Dental Class 2 872.4760 2023-10-28
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2023-10-27
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-10-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
KBA Rasp, Nasal Ear, Nose, Throat Class 1 874.4420 2023-10-30
EKB Explorer, Operative Dental Class 1 872.4565 2023-10-30
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2023-10-30
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2023-10-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-08-25
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2023-10-27
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-10-27
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2025-03-24
JEY Plate, Bone Dental Class 2 872.4760 2023-10-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-01-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-13
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2026-01-13
KBM Dissector, Tonsil Ear, Nose, Throat Class 1 874.4420 2023-10-30
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
FFO Retractor, Self-Retaining Gastroenterology, Urology Class 1 876.4730 2023-10-27
HWW Countersink Orthopedic Class 1 888.4540 2023-10-27
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2023-10-28
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2024-07-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-07-16
FFQ Speculum, Rectal Gastroenterology, Urology Class 1 876.4730 2023-10-30
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2023-10-30
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2023-10-27
KIJ Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2023-10-30
EML Chisel, Bone, Surgical Dental Class 1 872.4565 2023-10-30
HDQ Dilator, Cervical, Fixed Size Obstetrics/Gynecology Class 1 884.4530 2023-10-30
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-10-27
HWT Template Orthopedic Class 1 888.4800 2023-10-27
EIG Retractor, All Types Dental Class 1 872.4565 2023-10-30
KAE Forceps, Ent Ear, Nose, Throat Class 1 874.4420 2023-10-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-01-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
GXN Plate, Cranioplasty, Preformed, Non-Alterable Neurology Class 2 882.5330 2023-10-28
HNC Specula, Ophthalmic Ophthalmic Class 1 886.4350 2023-10-30
JEY Plate, Bone Dental Class 2 872.4760 2023-10-28
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 2023-10-27
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 2023-10-27
GAI Stripper, Vein, Reusable General, Plastic Surgery Class 1 878.4800 2023-10-27
KBD Scissors, Nasal Ear, Nose, Throat Class 1 874.4420 2023-10-30
FNY Basin, Emesis General Hospital Class 1 880.6730 2023-10-30
KAS Knife, Nasal Ear, Nose, Throat Class 1 874.4420 2023-10-30
JYT Pick, Microsurgical Ear Ear, Nose, Throat Class 1 874.4420 2023-10-27
JEY Plate, Bone Dental Class 2 872.4760 2023-11-15
JEY Plate, Bone Dental Class 2 872.4760 2023-10-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-03-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-20
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2023-10-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-10-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-10-27
HND Spatula, Ophthalmic Ophthalmic Class 1 886.4350 2023-10-30
KCH Hook, Tracheal Ear, Nose, Throat Class 1 874.4420 2023-10-30
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2023-10-30
JXS Block, Cutting, Ent, Sterile Ear, Nose, Throat Class 1 874.3540 2023-10-30
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-10-27
HXB Probe Orthopedic Class 1 888.4540 2023-10-27
KAI Mirror, Ent Ear, Nose, Throat Class 1 874.4420 2023-10-30
JEX Plier, Orthodontic Dental Class 1 872.4565 2023-10-30
JEY Plate, Bone Dental Class 2 872.4760 2023-10-27
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2023-10-30
HHM Sound, Uterine Obstetrics/Gynecology Class 1 884.4530 2023-10-27
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2023-10-27
HGC Clamp, Uterine Obstetrics/Gynecology Class 1 884.4520 2023-10-27
KCJ Applicator, Ent Ear, Nose, Throat Class 1 874.5220 2023-10-27
HWX Tap, Bone Orthopedic Class 1 888.4540 2023-10-27
KCB Tube, Tonsil Suction Ear, Nose, Throat Class 1 874.4420 2023-10-27
EJY Pliers, Operative Dental Class 1 872.4565 2023-10-30
NNU Scissors, Wire Cutting, Ent, Non-Sterile Ear, Nose, Throat Class 1 874.3540 2023-10-30
HWK Trephine Orthopedic Class 1 888.4540 2023-10-27
PPT Cranial Surgical Planning And Instrument Guides Neurology Class 2 882.4310 2023-10-28
LYS Bone Mill Orthopedic Class 1 888.4540 2023-10-30
JEY Plate, Bone Dental Class 2 872.4760 2023-10-28
JEY Plate, Bone Dental Class 2 872.4760 2023-10-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-10-28
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2023-10-28
PBJ Cranial Distraction System Neurology Class 2 882.5330 2023-10-28
NEI Prosthesis, Condyle, Mandibular, Temporary Dental Class 2 872.4770 2023-10-27
FDG Retractor, Fiberoptic Gastroenterology, Urology Class 1 876.4530 2023-10-27
HDL Retractor, Vaginal Obstetrics/Gynecology Class 1 884.4520 2023-10-30
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2023-10-27
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-10-28
DZJ Driver, Wire, And Bone Drill, Manual Dental Class 2 872.4120 2023-10-28
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2023-10-30
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 2023-10-30
MQN External Mandibular Fixator And/Or Distractor Dental Class 2 872.4760 2023-10-28
HTW Bit, Drill Orthopedic Class 1 888.4540 2023-10-30
KBZ Snare, Tonsil Ear, Nose, Throat Class 1 874.4420 2023-10-27
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2023-10-30
PPT Cranial Surgical Planning And Instrument Guides Neurology Class 2 882.4310 2023-10-28
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-10-27
PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic Class 2 888.3030 2023-10-28
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2023-10-28

Official Correspondent

No official correspondent registered.

US Agent Details

Melissa Bachorski Business: KLS-Martin L.P. Email: raqa-admin_na@KLSmartin.com Phone: (800) 6251557

Related Public Records

Same Entity

KLS Martin SE & Co. KG
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9681383 KLS Martin SE & Co. KG Freiburg Baden-Wurttemberg, DE
3014201171 KLS Martin Malaysia Sdn. Bhd. Simpang Ampat Pulau Pinang, MY
3036795921 KLS MARTIN SE & CO. KG Fridingen Baden-Wurttemberg, DE
1057946 KLS-Martin L.P. Jacksonville, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06

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Z-0030-2026 CHANGE HEALTHCARE CANADA COMPANY 2
Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012 Philips Healthcare Inc. 2
MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610905. Last updated year: 2026. Please use registration number 9610905 when referencing this establishment in official correspondence.
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